Efficacy and Safety of FEXUCLUE Tab. In Patients With Acute or Chronic Gastritis

NCT ID: NCT06948487

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 12000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-17
• Study Completion Date: 2027-06-03

Brief Summary

This study aims to evaluate the efficacy of Fexuclue tablets in improving gastrointestinal symptoms based on patient-reported outcomes (PROs), by comparing assessments before and after treatment.

Detailed Description

In this observational study, patient-reported data will be collected using an electronic application (e-PRO). The survey on subjective symptoms will be administered twice-once before and once after the administration of Fexuclue tablets. Additionally, a survey on medication convenience will be conducted once at 2 weeks (up to a maximum of 4 weeks) post-administration.

At the same time point (2 to 4 weeks after administration), patients will self-assess their overall improvement through the e-PRO application. Investigators will also evaluate final improvement based on clinical judgment in a real-world setting and record the outcome in the Case Report Form (CRF).

Conditions

Gastritis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Fexuclue® Tab

Fexuclue® Tab Fexuclue® Tab Fexuprazan Hydrochloride 10mg

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Adult subjects between the ages of 19 and 75 years at the time of obtaining written informed consent.
• Subjects who are scheduled to receive Fexuclu tablets (fexuprazan) in accordance with the approved indication.
• Subjects who present with at least one subjective symptom requiring medical treatment
• Subjects who are capable of understanding the information provided, have voluntarily decided to participate in this observational study, and have provided written informed consent for the use of their personal data.

Exclusion Criteria

• Individuals who fall under any contraindications for the administration of Fexuclu tablets (fexuprazan) as specified in the approved labeling.
• Individuals who are deemed by the investigator (attending physician) to be inappropriate for participation in this observational study for any reason not otherwise specified.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jingun Kim, Dr.

Role: PRINCIPAL_INVESTIGATOR

Masong Kim Internal Medicine Clinic

Locations

Masong Kim Internal Medicine Clinic

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

So Heui Kim

Role: CONTACT

2210325@daewoong.co.kr

82-10-2994-5887

Facility Contacts

Jingun Kim

Role: primary

Other Identifiers

DW_FEX_DB_03

Identifier Type: -

Identifier Source: org_study_id